DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 30 December 2025 has been entered.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-19 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a product of nature without significantly more.
MPEP § 2106 sets forth the Subject Matter Eligibility Test to determine if a claim is directed to patent eligible subject matter. The following analysis is presented within the framework enumerated in MPEP § 2106.
Step 1 Is the claim is directed to a statutory category of invention? Applicant’s claims are directed to a product; thus, the answer to Step 1 is Yes.
Step 2A, Prong One Is the claim directed to a judicial exception? In this case, Claims 1-13, 16 and 17 are directed to a fat blend and claims 14, 15, 18 and 19 are directed to nutritional compositions comprising the fat blend. All of the positively recited components in the present claims are naturally occuring. Therefore, the claims do recite products of nature. MPEP § 2106.04(b) states that “When a claim recites a nature-based product limitation, examiners should use the markedly different characteristics analysis discussed in MPEP § 2106.04(c) to evaluate the nature-based product limitation and determine the answer to Step 2A.”
Markedly different characteristics analysis
MPEP § 2106.04(c)(I) states that “if the nature-based product limitation is not naturally occurring, for example due to some human intervention, then the markedly different characteristics analysis must be performed to determine whether the claimed product limitation is a product of nature exception…”. To perform the markedly different characteristic analysis, MPEP § 2106.04(c)(II) states “The markedly different characteristics analysis compares the nature-based product limitation to its naturally occurring counterpart in its natural state. Markedly different characteristics can be expressed as the product’s structure, function, and/or other properties…”.
In this case, there is no modification of the ingredients within the claimed composition. Page 6 of applicant’s remarks submitted 30 December 2025 states “the claimed fat blend thus naturally mimics the sn-2 fatty acid profile of human milk fat”. The fact pattern in this application is similar to that found in Funk Brothers Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 131 (1948) which stated “Each species has the same effect it always had. The bacteria perform in their natural way. Their use in combination does not improve in any way their natural functioning. They serve the ends nature originally provided and act quite independently of any effort of the patentee”. In the instant application each naturally occurring claim element has the same effect it always had. The claimed naturally occurring products perform in their natural way. Their use in combination does not improve in any way their natural functioning. They serve the ends nature originally provided and act quite independently of any effort of the patentee. As such, the characteristics of the claimed invention are not markedly different from their naturally occurring counterparts.
Therefore, the claims are drawn to mixtures of naturally occurring products. Thus, the answer to Step 2A, Prong One, is Yes.
Step 2A, Prong Two: Does the claim recites additional elements that integrate the judicial exception into a practical application? As discussed in MPEP § 2106.04(d)(2) this evaluation is performed by identifying whether there are additional elements recited in the claim beyond the judicial exception and evaluating these additional elements to determine whether the claim as a whole integrates the exception into a practical application. In this case, only the composition is claimed. There is no practical application claimed. Thus, the answer to Step 2A, Prong Two, is No.
Step 2B: Do the claims recite additional elements that amount to significantly more than the judicial exception? MPEP § 2106.05 states that this evaluation is performed by “Evaluating additional elements to determine whether they amount to an inventive concept requires considering them both individually and in combination to ensure that they amount to significantly more than the judicial exception itself.” In this case, there are no additional elements, therefore the answer for Step 2B is no. As such, Claims 1-19 are not directed to patent eligible subject matter.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-6, 8-12 and 14-19 are rejected under 35 U.S.C. 103 as being unpatentable over Kline USPGPub 20170360076 and Sorensen “Human Milk Fat Substitute from Butterfat: Production by Enzymatic Interesterification and Evaluation of Oxidative Stability” J Am Oil Chem Soc (2010) 87:185–194.
Claims 7 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Kline USPGPub 20170360076 and Sorensen “Human Milk Fat Substitute from Butterfat: Production by Enzymatic Interesterification and Evaluation of Oxidative Stability” J Am Oil Chem Soc (2010) 87:185–194 as applied to claim 1 in further view of applicant’s admitted prior art (AAPA)
Regarding claims 1, 2, 6 and 8, Kline teaches an infant formula wherein at least 65% of the total palmitic acid is sn-2 palmitate because this content closely mirrors human milk. [0048] Kline achieves this palmitic acid content by using a mix of vegetable oils and bovine milk fat. [0053] The oil mix of Kline comprises sn-2 palmitate in an amount of 2-15% of total fatty acids present. [0051]
Kline is silent regarding the proportions of vegetable lipid and bovine milk fat and the specific fatty acid profile of the bovine milk fat.
Sorensen teaches a human milk fat substitute comprising bovine butter fat having a molecular structure and fatty acid composition very similar to human milk. (pg. 193) The LCSFA C12:0-C18:0 content of the milk fat of Sorensen at the sn-2 position is
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about 82 wt%. (Table 3, acidolysis+fractionation, see below, “others” MW estimated as an avg of C4-C18 MWs)
Both Kline and Sorensen are directed to compositions having a fatty acid profile
with high contents of palmitic acid at the sn-2 position. It would have been obvious to one of ordinary skill in the art at the time the application was filed to have used the milk fat of Sorensen in Kline since the milk fat of Sorensen has a high content of sn-2 palmitate and a molecular structure and fatty acid composition very similar to human milk.
It would have been obvious to one of ordinary skill in the art at the time the application was filed to have varied the proportions of vegetable lipid and bovine milk fat to achieve a palmitic acid content at the sn-2 position of at least 65%. Therefore, the proportions of vegetable lipid source and milk fat composition recited in claims 1 and 8 are the result of the obvious optimization of the prior art. The milk fat composition of Sorensen comprises about 82 wt% sn-2 LCSFA C12:0-C18:0 which overlaps with the content of sn-2 LCSFA C12:0-C18:0 recited in claims 1, 2 and 6. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990)
Although Kline and Sorenson do not disclose that the fat blend contains only “natural” fats or oils and does not contain any chemically or enzymatically synthesized fats or oils, it is noted that “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process”, In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) . Further, “although produced by a different process, the burden shifts to applicant to come forward with evidence establishing an unobvious difference between the claimed product and the prior art product”, In re Marosi, 710 F.2d 798, 802, 218 USPQ 289, 292 (Fed. Cir.1983). See MPEP 2113.
Therefore, absent evidence of criticality regarding the presently claimed lack of enzymatic treatment and given that the modification of Kline with Sorenson produces a fat blend materially indistinguishable from the composition claimed, the modification of Kline with Sorenson clearly meets the requirements of present claim 1.
Therefore, the modification of Kline with Sorensen renders obvious claims 1, 2, 6 and 8.
Regarding claims 3 and 4, the limitations of these claims are product-by-process limitations that do not impart any material characteristics to the product claimed. The claims do not specify the proportions of the components of the milk fat fraction mixtures recited and therefore products reading on such are materially indistinguishable from the from the milk fat composition of Sorensen.
Regarding claims 5, 16 and 17, the milk fat of Sorensen is obtained by crystallization fractionation (Fig. 1) as recited in claim 5. Sorensen is silent regarding dry fractionation as recited in claims 16 and 17, however, these product-by-process limitations do not impart any material characteristics to the claimed composition that would be distinguishing from the composition of Sorensen.
Regarding claims 7 and 13, the milk fat composition of Sorensen comprises butyric acid in an amount of about 2 wt%. (See table) AAPA demonstrates that milk fat fractions are rich in short chain fatty acids, such as butyric acid, which are known to have a positive effect on immune modulation and contribute to an appreciated flavor. (pg. 3 of applicant’s specification)
It would have been obvious to one of ordinary skill in the art at the time the application was filed to have included butyric acid in the composition of Kline in an amount suitable to have a positive effect on immune modulation and to contribute to an appreciated flavor. Therefore, the proportions of butyric acid recited in claims 7 and 13 merely reflect the obvious optimization of the prior art in light of the level of ordinary skill in the art.
Regarding claims 9 and 10, Kline teaches mixtures of milk fat and soybean oil, high oleic safflower oil and sunflower oil. [0053]
Regarding claims 11 and 12, the modification of Kline with Sorensen yields a fat blend comprising soybean oil, high oleic safflower oil and sunflower oil and milk fat having contents of sn-2 palmitic acid as claimed and disclosed by applicant for the same purpose as claimed and disclosed by applicant, namely, use in formula. While the specific proportions of LCSFA C12:0-C18:0 recited in claims 11 and 12 are not explicitly disclosed by the prior art, the prior art clearly recognizes the importance of C16:0 at sn-2 which forms the entirety of applicant’s inventive concept. As such, the optimization of the palmitic acid content of the fat blend by extension involves the optimization of the rest of the LCSFA C12:0-C18:0. Therefore, the limitations of claims 11 and 12 do not provide a patentable distinction over the prior art.
Regarding claims 14, 15, 18 and 19, Kline teaches a nutritional composition that is suitable as an infant formula or follow-on formula as recited in claims 15, 18 and 19. Kline does not teach the specific proportion of the fat blend of the infant formula based on dry weight, however, it would have been obvious to one of ordinary skill in the art at the time the application was filed to have varied the content of the fat blend in the infant formula depending on the caloric density desired. As such, the limitations of claims 14, 15, 18 and 19 are rendered obvious by the modification of Kline with Sorensen.
Response to Arguments
Applicant's arguments filed 30 December 2025 have been fully considered but they are not persuasive.
In response to applicant's arguments against the references individually on pages 6-8 of the remarks, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Applicant asserts on page 8 of the remarks that the modification of Kline with Sorensen fails to read on claim 1 because the presently amended claims recite that the fat blend contains only natural fats or oils and does not contain any chemically or enzymatically modified fats or oils. This assertion is not found persuasive as it fails to identify any fats or oils present in the modification of Kline with Sorensen that are not naturally occurring. Applicant has not explained how the claimed product-by-process limitations impart any material characteristics to the claimed fat blend that distinguish it from the blend produced by the modification if Kline proposed in the rejection. As such, applicant’s assertion is not found persuasive.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michele L Jacobson whose telephone number is (571)272-8905. The examiner can normally be reached Monday through Friday from 10-6.
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/Michele L Jacobson/Primary Examiner, Art Unit 1793